# FDA 483 - Genetech Inc - June 22, 2018

Source: https://www.globalkeysolutions.net/records/483/genetech-inc/6f95c3f2-4496-43cf-b8af-ac6d10461b25

> FDA 483 for Genetech Inc on June 22, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genetech Inc
- Inspection Date: 2018-06-22
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Genetech, Inc. in San Diego, CA, was cited for numerous deficiencies during an inspection of its umbilical cord blood operations. The firm failed to properly determine and document donor eligibility, use FDA-licensed communicable disease tests, and establish a functional quality control unit. Significant issues were also noted in aseptic processing, environmental monitoring, process validation, stability testing, and record-keeping, indicating a pervasive lack of control and documentation.

## Related Documents

- [483 - 2018-06-22](https://www.globalkeysolutions.net/records/483/genetech-inc/8ea00326-5d94-49c7-a6f2-4d44df31d881)

## Related Officers

- [Tania Y. Hall](https://www.globalkeysolutions.net/people/tania-y-hall/94f342b2-a5f3-4ff1-ae5a-7f75fefe2214)

Company: https://www.globalkeysolutions.net/companies/genetech-inc/00af7a0b-75ce-4c2a-865d-6580b0ff15e5

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6